Sections in Pharmaceutical Formulation Facility

This article describes about Different Sections/Areas available In the Pharmaceutical Formulations Facility :

Different Sections/Areas in Pharmaceutical Formulations Facility.

Oral Solid Dosages and Sterile Preparations :

Warehouse :

1. Raw Material Store – Quarantine area/Under Test Area/Approved Area/ Rejected Room (API/Excipient & Solvent)
2. Packing Material Store – Quarantine area/Under Test Area/Approved Area/ Rejected Room (For Primary/Secondary/Tertiary material storage area)
3. Finished Goods Store –  Under Test Area/Approved Area/ Rejected Room

Tablet :

1. Dispensing area – Raw material Dispensing (API/Excipient/Solvent) /Packing material Dispensing (Primary/Secondary/Tertiary PM)
2. Dispensed Material Hold Area
3. Granulation- Wet Granulation area/Dry Granulation Area
4. Granules Quarantine area
5. Compression – D/B/DB/BB/BBS Tooling – Dedusting and Metal Detector Unit
6. Coating- Different sizes Coating Pan
7. Inspection
8. Tablet Quarantine Area
9. Change part /Ancillary Room
10. Packing – ALU/ALU pack/ALU/PVC Pack/Bottle Pack – Camera system
11. Packing machine change part room
12. Stereo Handling room
13. Change rooms for man and material movement shall be separate from Dispensing, Manufacturing and Packing area.
14. Track and Trace System (Serialization and Aggregation system).
15. Pharma Code Detection systems (Primary/Secondary packing material)

Capsule :

1. Dispensing area – Raw material Dispensing (API/Excipient/EHG Capsule) /Packing material Dispensing (Primary/Secondary/Tertiary).
2. Dispensed Material Hold Area
3. Granulation/Blending
4. Granules Quarantine area
5. Capsule Filling – line machines + Metal Detector Unit
6. Check weighing area
7. Inspection area
8. Filled Capsule Quarantine area
9. Filling machine Change part room
10. Packing – ALU/ALU pack/ALU/PVC Pack/Bottle Pack- Camera system
11. Packing machine change part room.
12. Stereo Handling room
13. Change rooms for man and material movement shall be separate from Dispensing, Manufacturing and Packing area.
14. Track and Trace System (Serialization and Aggregation system).
15. Pharma Code Detection systems (Primary/Secondary packing material)

External Preparations :

1. Dispensing area – Raw material Dispensing (API/Excipient/Solvent) /Packing material Dispensing (Tube/Secondary/Tertiary).
2. Tube Decartoning area
3. Dispensed material Hold Area
4. Manufacturing Area
5. Tube filling Area
6. Filling Machine change part area.
7. Stereo Handling room
8. Tube Packing area.
9. Change rooms for man and material movement shall be separate from Dispensing, Manufacturing and Packing area.
10. Track and Trace System (Serialization and Aggregation system).
11. Pharma Code Detection systems (Primary/Secondary packing material)

Dry Powder Injections  :

1. Decartoning Area
2. Washing Area-Recycled water (WFI+ Purified water) – Compressed Air / Purified water- Compressed Air /WFI water- Compressed Air
3. Autoclaving area- 121.4 Degree for 30 Minutes
4. Sterilization and Depyrogenation- 300 to 340 Degree
5. Blending Area (If Needed) – Four Change room Concept for entrance
6. Filling and Bunging area- Four Change room Concept for entrance
7. Sealing Area
8. Labelling Area
9. Packing Area
10. Change rooms for man and material movement shall be separate from Dispensing, Manufacturing and Packing area.
11. Track and Trace System (Serialization and Aggregation system).
12. Pharma Code Detection systems (Secondary packing material)

Quality Control:

1. Raw material section
2. Packing material Section
3. Inprocess Testing section
4. Finished product Testing section
5. Water Testing
6. AMV/AMT section if any
7. Stability Section
8. Instrument Calibration Section
9. Documentation (Preparations or revision of STP/Spec/QMS/SOP)

Microbiology for OSD/External Preparations

1. Culture/Media Handling Area
2. Culture/media Storage Area
3. Collected sample storage area
4. Incubator Handling and maintenance
5. MLT (Microbial Limit Testing) Area
6. Water Testing Area
7. Environmental Monitoring

Microbiology for Sterile Preparations

1. Culture/Media Handling Area
2. Culture/media Storage Area
3. Collected sample storage area
4. Incubator Handling and maintenance
5. MLT (Microbial Limit Testing) Area
6. Water Testing Area
7. Environmental Monitoring
8. Sterility and BET – Bacterial Endotoxin Test (For Injection)

Quality Assurance :

1. Inprocess Quality Assurance (IPQA)
2. Quality Management System (QMS)- Deviations/Change Control/Incidents/OOS/OOT
3. Validations – Process/Cleaning/Routine/Non Routine
4. Annual product quality Review (APQR)
5. BMR/BPR preparations & Issuance
6. Regulatory compliance documentations
7. Vendor Qualifications/Approvals
8. General documentations Upkeepment
9. Pest control Management- Record Upkeepment and Control

Engineering for OSD/External Preparations :

1. Water System- (Raw water /Potable water /Purified water)
2. Utility (Air Compressor, Boiler, Chiller/DX for HVAC or air compressor, HVAC)
3. ETP (If Cepha / Hormone- Deactivation procedure shall be include)

Engineering for Sterile Preparations :

1. Water System- (Raw water /Potable water /Purified water/WFI/PSG)
2. Pure Steam Generator Unit  for Autoclave or Depyrogenated Tunnel
3. Utility (Air Compressor, Boiler, Chiller/DX, HVAC)
4. ETP (If Cepha / Hormone- Deactivation procedure shall be include)

Research and Development :

1. F&D (Formulation and Development)
2. ADL/AR&D (Analytical Development Laboratory/Analytical Research and development)
3. Stability